What is the translation of " INITIAL AUTHORISATION " in Slovenian?

• začetno dovoljenje
• prvotno dovoljenje
• prvotno odobritev

Examples of using Initial authorisation in English and their translations into Slovenian

Operating conditions and initial authorisation.
Pogoji poslovanja in začetno dovoljenje.

A CCP shall, without undue delay, notify the competent authority of any material changes affecting the conditions for the initial authorisation.
CCP takoj obvesti pristojni organ o kakršnih koli pomembnih spremembah glede pogojev za začetno dovoljenje.

Review of conditions for initial authorisation.
Redni pregled izpolnjevanja pogojev za začetno dovoljenje.

They shall require investment firms to notify the competent authorities of any material changes to the conditions for initial authorisation.
Od investicijskih podjetij zahtevajo, da pristojne organe obvestijo o kakršnih koli pomembnih spremembah glede pogojev za začetno dovoljenje.

This is true at all stages: initial authorisation, ongoing supervision and enforcement.
To velja za vse ravni: začetno odobritev, tekoč nadzor in izvrševanje.

A CCP shall comply at all times with the conditions necessary for the initial authorisation.
CCP ves čas izpolnjuje pogoje, ki jih je morala izpolnjevati za začetno dovoljenje.

The possibility of following centralised procedures even if the initial authorisation for a pharmaceutical product for adults has been obtained through national procedures constitutes a genuine opportunity.
Tudi če je bilo začetno dovoljenje za farmacevtski izdelek za odrasle pridobljeno po nacionalnih postopkih, možnost spremljanja centraliziranih postopkov predstavlja resnično priložnost.

Ancillary services permitted under, but not explicitly listed in Section B of the Annex, not covered by the initial authorisation;
Pomožne storitve, dovoljene na podlagi oddelka B, a v njem niso izrecno navedene, ki niso vključene v prvotno dovoljenje;

(i) the initial authorisation to operate a nuclear installation is based on an appropriate safety analysis and a commissioning programme demonstrating that the installation, as constructed, is consistent with design and safety requirements;
(i) začetno dovoljenje za obratovanje jedrskega obrata temelji na primerni varnostni analizi in programu prevzemanja, ki naj pokažeta, da je objekt, kot je zgrajen, skladen s projektnimi ter varnostnimi zahtevami;

A common set of basic provisions will govern the conditions for the initial authorisation and organisation of all AIFM.
Skupni sklop osnovnih določb bo urejal pogoje za začetno dovoljenje in organizacijo vseh UAIS.

In particular, in the spirit of the principle of mutual recognition, measures should be taken, involving the placing of limits on the number of elements that the competent authority may examine, so as to make it easier to obtain an entry-into-service authorisation in a Member State other than the one which issued the initial authorisation.
S stališča načela vzajemnega priznavanja je zlasti nujno, da se poenostavi postopek za dovoljenje za začetek obratovanja v drugi državi članici kakor tisti, ki je odobrila prvo dovoljenje, in da se pri tem omejijo elementi, ki bi jih pristojni organ lahko preveril.

A CCP wishing to extend its business to additional services or activities not covered by the initial authorisation shall submit a request for extension.
CCP, ki želi razširiti svoje poslovanje na dodatne storitve ali dejavnosti, ki niso zajete v začetnem dovoljenju, vloži prošnjo za razširitev.

If the Commission decision confirms the initial national authorisation, the competent authority that proposed to refuse to recognise a national authorisation, or to recognise the national authorisation subject to certain conditions, shall without delay authorise the biocidal product concerned in accordance with the initial authorisation.
Če odločitev Komisije potrdi prvotno nacionalno dovoljenje, pristojni organ, ki je predlagal zavrnitev priznanja nacionalnega dovoljenja ali priznanje nacionalnega dovoljenja pod določenimi pogoji, nemudoma izda dovoljenje za zadevni biocidni pripravek v skladu s prvotnim dovoljenjem.

According to Article 15 of EMIR, a"CCP wishing to extend its business to additional services or activities not covered by the initial authorisation shall submit a request for extension to the CCP's competent authority.
CNS, ki želi razširiti svoje poslovanje na dodatne storitve ali dejavnosti, ki niso zajete v začetnem dovoljenju, vloži prošnjo za razširitev na pristojni organ CNS.

The reporting Member State for the application referred to in paragraph 1 shall be the reporting Member State for the initial authorisation procedure.
Država članica poročevalka za vlogo iz odstavka 1 je država članica, ki je to nalogo opravljala tudi v postopku osnovne odobritve.

The review looked at results of the open-label‘GISSI Prevenzione' study performed in 1999 which supported the initial authorisation of these medicines, as well as more recent randomised controlled clinical trials, retrospective cohort studies and meta-analyses.
Pregled je vključeval oceno rezultatov odprte študije GISSI Prevenzione, ki je bila izvedena leta 1999 in je podpirala prvotno odobritev teh zdravil, ter retrospektivne kohortne študije, novejše randomizirane kontrolirane študije in rezultate meta-analiz.

To ensure coherence those criteria should be consistent with the criteria applied in relation to shareholders and management in the initial authorisation procedure.
Da se zagotovi skladnost, morajo biti ta merila v skladu z merili, ki se uporabljajo za delničarje in upravljanje v postopku pridobitve začetnega dovoljenja.

I therefore totally agree with the Commission's proposal to harmonise the procedures for authorising variations made to medicines, regardless of the initial authorisation procedure, as this simplification will streamline the entire system and, above all, guarantee a higher level of public health protection.
Zato se v celoti strinjam s predlogom Komisije o uskladitvi postopkov za odobritev sprememb pri zdravilih ne glede na postopek izdaje prvih dovoljenj, saj bo ta poenostavitev racionalizirala celoten sistem in predvsem zagotovila višjo raven zaščite javnega zdravja.

We in the Commission have set a deadline of six months in all cases, because we will then have to- and we will want to- find out what has happened in the six months since our initial authorisation of those plans.
V Komisiji smo v vseh primerih postavili časovni rok šestih mesecev, saj bomo potem morali- in to si tudi želimo- ugotoviti, kaj se je zgodilo v teh šestih mesecih od naše prvotne odobritve teh načrtov.

ESMA shall monitor that data reporting services providers comply at all times with the conditions for initial authorisation established under this Title.
ESMA spremlja, ali izvajalci storitev sporočanja podatkov nepretrgoma izpolnjujejo pogoje za prvotno dovoljenje iz tega naslova.

An authorisation mechanism should be provided to allow for this extension, while avoiding the re-assessment of the application by all the Member States concerned which were involved in the initial authorisation of the clinical trial.
Za to razširitev bi bilo treba predvideti mehanizem odobritve, pri katerem vsem zadevnim državam članicam, ki so sodelovale pri osnovnem postopku odobritve kliničnega preskušanja, ne bi bilo treba ponovno ocenjevati vloge.

Without prejudice to Article 21(1), all relevant data required under Article 20 that it has generated since the initial authorisation or, as appropriate, previous renewal; and.
Brez poseganja v člen 21(1) vse ustrezne podatke, ki se zahtevajo v skladu s členom 20 in so bili ustvarjeni po prvotni odobritvi ali predhodnem podaljšanju, kakor je primerno, in.

ESMA, or the national competent authority where relevant, shall monitor that data reporting service providers comply at all times with the conditions for initial authorisation established under this Title.
ESMA ali, kadar je ustrezno, nacionalni pristojni organ spremlja, ali izvajalci storitev sporočanja podatkov ves čas izpolnjujejo pogoje za prvotno dovoljenje iz tega naslova.

They shall also ensure that competent authorities monitor that regulated markets comply at all times with the conditions for initial authorisation established under this Title.
Zagotovijo tudi, da pristojni organi spremljajo, da regulirani trgi ves čas izpolnjujejo pogoje za začetno dovoljenje iz tega naslova.

Member States shall require that an investment firm authorised in their territory comply at all times with the conditions for initial authorisation established in Chapter I.
Države članice zahtevajo, da investicijsko podjetje, ki je pridobilo dovoljenje na njihovem ozemlju, ves čas izpolnjuje pogoje za začetno dovoljenje iz poglavja I.

They shall also ensure that competent authorities monitor that data reporting services providers comply at alltimes with the conditions for initial authorisation established under this Title.
Zagotovijo tudi, da pristojni organi spremljajo, ali izvajalci storitev sporočanja podatkov ves čas izpolnjujejo pogoje za začetno dovoljenje iz tega naslova.

In the case of investment firms which provide only investment advice, Member States may allow the competent authority to delegate administrative, preparatory or ancillary tasks related to the review of the conditions for initial authorisation, in accordance with the conditions laid down in Article 48(2).
V primeru investicijskih podjetij, ki izvajajo samo investicijsko svetovanje, lahko države članice pristojnemu organu dovolijo, da prenese administrativne, pripravljalne ali pomožne naloge v zvezi s pregledovanjem izpolnjevanja pogojev za začetno dovoljenje v skladu s pogoji iz člena 48(2).